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U.S. Department of Health and Human Services

Class 1 Device Recall 8870 Software Application Card Version AAA 02

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  Class 1 Device Recall 8870 Software Application Card Version AAA 02 see related information
Date Initiated by Firm August 24, 2004
Date Posted September 23, 2004
Recall Status1 Terminated 3 on December 13, 2005
Recall Number Z-1334-04
Recall Event ID 29849
PMA Number P860004 
Product Classification Pump, Infusion, Implanted, Programmable - Product Code LKK
Product 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer.
Code Information Software Version AAA 02, BBB 04, BBC 02, and BBD 01
Recalling Firm/
Manufacturer		 Medtronic Inc, Neurological & Spinal Division
800 53rd Ave Ne
Columbia Heights MN 55421-1241
For Additional Information Contact Mr. Patrick J. Eichers
763-505-3060
Manufacturer Reason
for Recall		 With the Model 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Programmer, users may have mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.
FDA Determined
Cause 2		 Other
Action Letters were distributed 8/24/2004 utilizing a courier with signed receipt upon delivery. The letters were signed for upon receipt at the consignee address, and the contents of the letter included a response form which can be faxed or mailed back to Medtronic. If any letters are returned as 'undeliverable', attempts will be made to telephone these consignees. A press release was issued on September 22, 2004 by Medtronic Inc. for all Version AAA 02 Model 8870 software application cards in the U.S.
Quantity in Commerce 3,218 cards distributed in US, plus 1,248 distributed outside of the US
Distribution These cards were distributed primarily in the USA, but also to countries in Europe, Middle East and Africa, Canada, Australia, Hong Kong, Latin America and Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.
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